Donna Heck

Background

About Donna Heck

PROFESSIONAL SUMMARY Earned PMP certification in July, 2013 and continuing education in project management. Clinical Research Professional with 20 years of clinical research experience; including Data Management, Monitoring, Trial Management and Vendor Management SME. Current position Project Manager at Syneos Health; dedicated resource to Sanofi. Prior experience includes Sr. Clinical Trial Manager at ICON working on Phase I-II Oncology trials; working as Trial Manager and Lead Clinical Trial Specialist at Merck, working as an RPS consultant for 7 years. Strong knowledge of FDA regulations, GCP and ICH guidelines. Therapeutic Areas of specialty include: oncology, systemic lupus erythematosus, and respiratory. Proven strengths include: Successful oversight of clinical trials leading to strong robust results while meeting timelines and keeping within budget. Decision making and problem resolution Developing creative process and strategies to ensure high quality while meeting strict timelines. Development of training materials for internal staff; Development of study manuals and study tools. Training and mentoring CTMs and in-house CRAs. Vendor Manager SME